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A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)

6 settembre 2019 aggiornato da: Eli Lilly and Company

A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib

The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

111

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Aalst, Belgio, 9300
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gent, Belgio, 9000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mechelen, Belgio, 2800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roeselare, Belgio, 8800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di, 138-736
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Francia
      • Montpellier, Francia, 34295
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toulouse, Francia, 31059
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Germania
      • Heidelberg, Germania, 69126
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ulm, Germania, 89081
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Israele
      • Beer Sheva, Israele, 84101
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jerusalem, Israele, 91120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kfar Saba, Israele, 44281
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Petah Tikva, Israele, 49100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tel Hashomer, Israele, 52621
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zerifin, Israele, 6093000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Italia
      • Milano, Italia, 20052
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orbassano, Italia, 10043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Olanda
      • Amsterdam, Olanda, 1081 HV
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Breda, Olanda, 4818 CK
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Regno Unito
    • Avon
      • Bristol, Avon, Regno Unito, BS10 5NB
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Greater London
      • London, Greater London, Regno Unito, W6 8RF
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hants
      • Southampton, Hants, Regno Unito, SO16 6YD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Manchester
      • Wythenshawe, Manchester, Regno Unito, M23 9LT
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oxford
      • Headington, Oxford, Regno Unito, OX3 7LE
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Spagna
      • Badalona, Spagna, 08916
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pamplona, Spagna, 31008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia, Spagna, 46026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama at Birmingham
    • California
      • La Jolla, California, Stati Uniti, 92037
        • University of California - San Diego
      • Los Angeles, California, Stati Uniti, 90048
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sacramento, California, Stati Uniti, 95817
        • University of California, Davis - Health Systems
      • Santa Monica, California, Stati Uniti, 90404
        • UCLA
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Georgetown University Medical Center IRB
    • Florida
      • Fort Myers, Florida, Stati Uniti, 33916-2233
        • Florida Cancer Specialists
      • Saint Petersburg, Florida, Stati Uniti, 33705
        • Florida Cancer Specialists
      • Tampa, Florida, Stati Uniti, 33612
        • H Lee Moffitt Cancer Center
    • Georgia
      • Athens, Georgia, Stati Uniti, 30607
        • Northeast Georgia Cancer Care, LLC
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa Hospital
    • Kansas
      • Westwood, Kansas, Stati Uniti, 66205
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Washington University Medical Center
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • Billings Clinic Research Center
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, Stati Uniti, 10032
        • Columbia University
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45242
        • Oncology Hematology Care Inc
    • Oregon
      • Portland, Oregon, Stati Uniti, 97213
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti, 37404
        • Tennessee Oncology PLLC
      • Memphis, Tennessee, Stati Uniti, 38120
        • The West Clinic
      • Nashville, Tennessee, Stati Uniti, 37203
        • Tennessee Oncology PLLC
    • Washington
      • Kirkland, Washington, Stati Uniti, 98034
        • MS Center at Evergreen
      • Seattle, Washington, Stati Uniti, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Stati Uniti, 98112
        • Group Health
      • Tacoma, Washington, Stati Uniti, 98405
        • MultiCare Health System

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of metastatic Stage IV NSCLC
  • At least 1 measurable extra-central nervous system (CNS) lesion
  • Documented radiographic progression while on continuous treatment with erlotinib monotherapy
  • Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
  • Determined to be MET diagnostic positive (+)
  • Availability of a tumor sample post-erlotinib progression
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Have adequate organ function

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
  • Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
  • Have a serious concomitant systemic disorder or significant cardiac disease
  • Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
  • Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
  • Have major surgery less than 2 weeks prior initiation of study treatment therapy
  • Pregnant or lactating women
  • Have symptomatic CNS metastasis

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
Droga: Emibetuzumab
Administered IV
Altri nomi:
  • LY2875358
Droga: Erlotinib
Somministrato per via orale
Sperimentale: Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
Droga: Emibetuzumab
Administered IV
Altri nomi:
  • LY2875358

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Lasso di tempo: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: Baseline to Objective Disease Progression or Death (Up to 24 Months)

PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.

Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Baseline to Objective Disease Progression or Death (Up to 24 Months)
Time to Progressive Disease
Lasso di tempo: Baseline to Objective Disease Progression (Up to 24 Months)
Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
Lasso di tempo: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Lasso di tempo: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
Lasso di tempo: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Overall Survival (OS)
Lasso di tempo: Baseline to Death Due to Any Cause (Up to 24 Months)
OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.
Baseline to Death Due to Any Cause (Up to 24 Months)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Lasso di tempo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Lasso di tempo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Lasso di tempo: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.

Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
Lasso di tempo: Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
Lasso di tempo: Baseline through 30-Day Follow-Up (Up to 24 Months)
Baseline through 30-Day Follow-Up (Up to 24 Months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2013

Completamento primario (Effettivo)

1 febbraio 2015

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

12 luglio 2013

Primo inviato che soddisfa i criteri di controllo qualità

12 luglio 2013

Primo Inserito (Stima)

16 luglio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 14208
  • I4C-MC-JTBC (Altro identificatore: Eli Lilly and Company)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Periodo di condivisione IPD

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Criteri di accesso alla condivisione IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • Protocollo di studio
  • Piano di analisi statistica (SAP)
  • Relazione sullo studio clinico (CSR)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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